Systems and methods for modulating pressure wave therapy

ABSTRACT

A processor-controlled, energy-based therapy apparatus includes a device configured to provide therapeutic energy to a patient and a processor that controls the output of the device. The output of the device is based on output profiles programmed into the processor. The output profiles include a therapeutic energy output profile and a ramp-up energy profile. The therapeutic energy output profile includes a desired target energy level and a therapeutic duration for controlling the output of the device during a therapeutic period. The ramp-up energy output profile includes an initial treatment energy level and a ramp-up duration for controlling the output of the device during a ramp-up period. The energy output specified by the ramp-up energy output profile incrementally increases over the ramp-up duration as a function of the desired target energy level and the ramp-up duration.

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 14/866,458, filed on Sep. 25, 2015, which is a continuation of U.S.application Ser. No. 13/096,403, filed on Apr. 28, 2011, which claimsthe benefit of U.S. Provisional Application No. 61/343,455, filed Apr.28, 2010. Each of the aforementioned applications is incorporated byreference herein in its entirety, and each is hereby expressly made apart of this specification.

BACKGROUND

Pressure wave therapy (also called shock wave therapy) is used fortreatment of a number of physiological conditions. A radial pressurewave device generates acoustic pulses that may be used in therapeuticapplications and may be beneficial in treating painful conditionsinvolving tendons, muscles and joints. Other clinical objectives ofradial pressure wave therapy may include increasing circulation,increasing metabolism, activating myofascial trigger points, treatingdisorders of tension insertion, and activation of muscle and connectivetissue, to speed healing and decrease pain. Because patientcharacteristics and conditions vary widely, treatment settings (e.g.,pressure wave and frequency) must be customized for each patient inorder to achieve successful treatment without causing intolerablediscomfort. However, many pressure wave therapy devices require anoperator to specify treatment settings prior to treatment, before thepatient or operator knows which settings will cause discomfort to thepatient. With such systems, an operator estimates an appropriate settingand applies the pressure wave therapy device to the patient. If thepatient experiences discomfort during the therapy, the operator stopsthe therapy session, manually re-adjusts the settings, then beginstreatment again. This procedure is time-consuming and may cause extendedpain and discomfort to the patient.

SUMMARY

The systems and techniques described herein improve these pressure wavetherapy devices by allowing an operator to more easily determine theproper pressure wave therapy settings for a particular patient, andeasily (in some cases, automatically) establish the proper settings,while minimizing patient discomfort.

In general, the processor-controlled, energy-based therapy apparatusesdisclosed herein provide a device configured to provide therapeuticenergy to a patient and a processor that controls the output of thedevice. The output of the device is based on output profiles programmedinto the processor. The output profiles include a therapeutic energyoutput profile and a ramp-up energy profile. In certain embodiments, thetherapeutic energy output profile includes a desired target energy leveland a therapeutic duration for controlling the output of the deviceduring a therapeutic period. The ramp-up energy output profile mayinclude an initial treatment energy level and a ramp-up duration forcontrolling the output of the device during a ramp-up period. The energyoutput specified by the ramp-up energy output profile may incrementallyincrease over the ramp-up duration as a function of the desired targetenergy level and the ramp-up duration.

In certain implementations, the ramp-up profile can control delivery ofpneumatic energy pulses during the ramp-up period. Such a ramp-upprofile may provide a pneumatic pressure level that incrementallyincreases as a function of the number of pulses delivered. In certainimplementations, the apparatus provides a steady-state level ofpneumatic therapy at an energy level that is at or below a patienttolerance level. When the ramp-up energy output profile reaches thedesired target energy level, the processor may maintain the applicationof the energy to a patient after the ramp-up period.

In certain implementations, the apparatus also includes a user input foridentifying when a threshold level of energy has been reached orexceeded. The apparatus may additionally or alternatively include a userinterface used by an operator for adjusting the ramp-up profile, aramp-up function, a desired target energy output, and a steady stateenergy level. In certain implementations, the processor can save inmemory information related to one or more output profiles.

Methods for applying energy-based therapy to a patient according to thedisclosed technology are also provided. Various alternative embodimentsand sub-features are also disclosed herein with respect toprocessor-controlled, energy-based therapy, as will become apparent inthe following description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a system diagram of a system for delivering pressure wavetherapy.

FIG. 2(a) is a flow diagram of a method for delivering pressure wavetherapy.

FIG. 2(b) is a flow diagram of an energy level change protocol for usein the method of FIG. 2(a).

FIG. 2(c) is a flow diagram of a duration change protocol for use in themethod of FIG. 2(a).

FIG. 3 is an illustration of a user interface for controlling a systemfor delivering pressure wave therapy.

FIG. 4 is a plot showing an amount of energy delivered in pulses ofpressure wave therapy implementations.

DETAILED DESCRIPTION

In general, the systems and methods described herein provide aprocessor-controlled, energy-based therapy apparatus for providingtherapeutic energy to a patient. In particular, a device for providingtherapeutic energy is controlled by a processor, and the output of thedevice is based on output profiles programmed into the processor. Theoutput profiles include a therapeutic energy output profile and aramp-up energy profile. In certain embodiments, the therapeutic energyoutput profile includes a desired target energy level and a therapeuticduration for controlling the output of the device during a therapeuticperiod. The ramp-up energy output profile may include an initialtreatment energy level and a ramp-up duration for controlling the outputof the device during a ramp-up period. The energy output specified bythe ramp-up energy output profile may incrementally increase over theramp-up duration as a function of the desired target energy level andthe ramp-up duration.

In some implementations, the device for providing therapeutic energy isa radial pressure wave device. Acoustic pulses may be created, forexample, by compressed air which accelerates a ballistic projectilethrough a tube inside an applicator component. Acceleration of theprojectile results in the creation of kinetic energy, which may becomeacoustic energy if the projectile impacts a transmitter tip at the endof the tube. The dimensions, materials, and other properties of thecomponents of the radial pressure wave device may be chosen to generateacoustic pulses that may reach different penetration depths that areselected for different clinical applications (e.g., 1-3 cm). Differentapplicator components may also be chosen for different clinicalobjectives.

Pressure wave therapy treatment sessions may vary according to apatient's therapeutic needs and other constraints. One treatment sessionincludes 2000 pulses per treatment area, with an average of twotreatment areas per patient, but the number of pulses per treatment andtreatment areas per patient may take any values.

FIG. 1 depicts a system diagram of a system for controlling anddelivering pressure wave therapy. The pressure wave therapy system 100includes a control unit 102, a pressure wave therapy device 110, and apain threshold indicator 112. The control unit 102 includes at least auser interface 104, a processor 106, and a memory 108. The control unit102 and the pressure wave therapy device 110 are both operated by anoperator, who may be a medical professional or physical therapist usingthe system 100 to apply therapy to a patient. The pain thresholdindicator 112 may be operated by either the patient or by the operator,who can observe the patient's reaction to the therapy to determine whenthe patient's pain threshold can be reached.

The pressure wave therapy device 110 operates in a similar manner to theradial pressure wave device described above. The control unit 102 is inconnection with the pressure wave therapy device 110 and sends commandsto the pressure wave therapy device 110 to control, for example, theenergy being delivered in pressure wave pulses, the frequency of thepulses, and the duration of the treatment. The system may contain aplurality of pressure wave therapy devices varying in energy range,shape, material, therapeutic applications, etc., that the operator canchoose from. In some implementations, the control unit 102 may beconfigured to control the operation of multiple pressure wave therapydevices simultaneously, as needed for therapy.

The user interface 104 is configured to output treatment information andreceive input from the operator related to the treatment via a touchscreen, a keyboard or keypad, a mouse, dials, a connectable memorymodule, or any other suitable input device. The processor 106 determinescontrol parameters from the input from the operator. It is understoodthat the term “processor” refers to any device capable of performing thesteps (or a subset of the steps) of a method for delivering pressurewave therapy, which is depicted in FIG. 2 and described in detail belowin relation to FIG. 2. Thus, the processor may include any combinationof special-purpose hardware, general purpose hardware, and software(e.g., embedded software).

The processor 106 may access treatment parameters and treatment programsfor different types of therapies (e.g., for use on different parts ofthe body) stored in a memory 108. In addition to treatment information,the memory 108 may also contain reference information related to thetreatment programs for the operator, such as diagrams for where and howto position the pressure wave unit 110 on the patient's body and whichpressure wave therapy device to use. This reference information isoutput on the user interface 104. The memory 108 may additionally storepatient-specific treatment information, such as the type of treatment apatient received in previous sessions and the patient's pain thresholddetermined in previous treatment sessions. The memory may store otherinformation related to shockwave therapy, such as background andrationale for using shockwave therapy and contraindications (e.g.,pregnancy, hemophilia, anticoagulant pharmaceuticals). In someimplementations, the elements of the control unit 102 are integratedinto the pressure wave therapy device 110.

During treatment, the operator or patient can use the pain thresholdindicator 112 to indicate when the patient's pain threshold has beenreached. During a ramp-up phase, the amount of energy delivered perpulse increases. If the energy level is unbearable, the patient or userengages the pain threshold indicator 112 to stop increasing the amountof energy or start delivering a slightly lower amount of energy. In someimplementations, engaging the pain threshold indicator 112 stops therapycompletely. The pain threshold indicator 112 may be, for example, amicrophone, a touch screen input, a button or dial on a handheldcomponent of the pressure wave therapy system, a particular series ofinputs (such as a double-click on a button or trigger on a handhelddevice), a button on a dedicated patient tolerance indicator signalline, a physiological sensor (such as an EEG sensor, an EMG sensor, anaccelerometer, etc.) capable of detecting patient discomfort, or anycombination thereof. In some implementations, the pain thresholdindicator 112 is on the pressure wave therapy device 110 to be easilyaccessible by the operator.

The control system, implemented by the processor 106 in FIG. 1, isconfigured to perform the process 200 depicted in FIG. 2(a). It willalso be understood that the steps depicted in FIG. 1 may be performed inany suitable order, and certain steps may be removed entirely (e.g.,when the pressure wave therapy device is not capable of performing aparticular step, or the step is performed by another device).

At the step 202, the processor 106 identifies a desired frequency ofpressure wave treatment. In certain embodiments, this frequency is inputby an operator (e.g., via a touch screen, connectable memory module,dial, or other suitable input device). One suitable implementation forreceiving user input is shown in FIG. 3. In other embodiments, thisfrequency is automatically identified by the processor when an operatorselects a treatment program or protocol that is stored in a look-uptable in the memory 108 coupled to the processor 106. In certainembodiments, this frequency is selected from a range of possiblefrequencies (e.g., approximately 0.5-35 Hz). In certain examples, theprocessor is configured to drive the opening and closing of a pneumaticvalve to cause pressure waves at the desired frequency.

At the step 204, the processor 106 identifies a desired duration ofpressure wave treatment. As was discussed above with reference to thestep 202, this duration may be input by an operator or automaticallyidentified by the processor 106. The duration may be identified in termsof a number of desired pulses (e.g., selected from the approximate rangeof about 10-10000 pulses) or a defined period of time (e.g., selectedfrom the approximate range of about 20-4000 seconds).

At the step 206, the processor 106 identifies a desired target energylevel for pressure wave treatment. As was discussed above with referenceto the step 202, this target energy level may be input by an operator orautomatically identified by the processor 106. In certain examples, theprocessor 106 is configured to drive the opening and closing of apneumatic valve a determined distance, thereby transmitting an amount ofpneumatic energy corresponding to the desired target energy level. Theenergy level may be identified in terms of a desired pressure (e.g.,selected from the range 1.4-5.0 bar) or any other desired unit ofacoustic energy.

At the step 208, the processor 106 determines whether the pressure wavetreatment should include an initial ramp portion. In making thisdetermination, the processor 106 may determine whether an operator inputhas been received indicating that a ramp portion should not be included(e.g., by reading the value of a binary ramp variable set by theprocessor 106 during a device set-up procedure). If the processor 106determines at the step 208 that an initial ramp portion should not beincluded in the pressure wave treatment, the processor 106 thendetermines a therapy profile (the step 220, discussed in detail below).

If the processor determines at the step 208 that an initial ramp portionshould be included in the pressure wave treatment, the processor 106will determine a ramp profile at the step 216. The ramp profile createdby the processor 106 may be based on one or more ramp profileparameters. In FIG. 2(a), at the step 210, the processor 106 identifiesa desired duration for the ramp portion. In certain embodiments, theduration of the ramp portion is a predetermined fraction of thetreatment duration identified at the step 204. For example, if thetreatment duration is identified at the step 204 as 3000 pulses and thepredetermined fraction is ⅓, the duration of the ramp portion identifiedat the step 214 is 1000 pulses. In certain embodiments, the duration ofthe ramp portion is input by an operator. In other embodiments, theduration of the ramp portion is automatically identified by theprocessor as discussed above with reference to the step 202. The profilemay be a function of the number of energy pulses to be applied, andbounded by a pre-determined upper energy limit that is pre-programmedinto the processor 106.

At the step 212, the processor 106 identifies an initial treatmentenergy level for the ramp portion. The initial treatment energy level isthe energy level which will be transmitted to the patient by thepressure wave therapy device 110 at the beginning of the ramp portion atthe start of treatment. In certain embodiments, the initial treatmentenergy level is less than the target treatment energy level identifiedat the step 206. The initial treatment energy may be a treatment energylevel that is expected to be comfortably received by the patient (i.e.,with minimal or no pain). In certain embodiments, the initial treatmentenergy level is a starting point from which the treatment energy will begradually increased (i.e., ramped) to the target treatment energy levelidentified at the step 206. The initial treatment energy level may beidentified in terms of a desired pressure (e.g., selected from theapproximate range of about 1.0-5.0 bar) or any other desired unit ofacoustic energy. As discussed above with reference to the step 202, theinitial treatment energy level may be input by an operator orautomatically identified by the processor 106. In certain embodiments,the initial treatment energy level is approximately 1.4 bar.

At the step 214, the processor 106 identifies a ramp function to befollowed during the ramp portion. The ramp function may specify how thepressure wave generated by the therapy device 110 will change over theramp portion (e.g., increasing or decreasing in magnitude). In certainembodiments, the ramp function is one or more of a linear function, anaffine function, a polynomial function, an exponential function, or anyother suitable function. Various ramp functions are described further inrelation to FIG. 4. As discussed above with reference to the step 202,the ramp function may be input by an operator or automaticallyidentified by the processor 106. In certain embodiments, the rampfunction specifies the energy to be transmitted to the patient over theduration of the ramp portion. In other embodiments, the ramp functionspecifies the change in energy to be applied from pulse to pulse as afunction of the number of pulses applied during the ramp portion. Forexample, in certain embodiments using a linear ramp function, the rampfunction specifies the pulse-to-pulse change in energy according to thefollowing equation:

$\left\lbrack {{{Energy}\mspace{14mu} {Change}\mspace{14mu} {per}\mspace{14mu} {Pulse}} = \frac{{{Target}\mspace{14mu} {Energy}} - {{Initial}\mspace{14mu} {Energy}}}{\frac{1}{3}*{Pulses}\mspace{14mu} {in}\mspace{14mu} {Treatment}\mspace{14mu} {Duration}}} \right.$

For example, using the linear ramp function defined above, if the targettreatment energy is 2.0 bar, the initial energy is 1.4 bar, and thereare 3000 pulses in the treatment duration, the energy change per pulseis calculated as follows:

$\frac{{2.0\mspace{14mu} {bar}} - {1.4\mspace{14mu} {bar}}}{\frac{1}{3}*3000\mspace{14mu} {pulses}} = {0.0006\mspace{14mu} {bar}\text{/}{{pulse}.}}$

At the step 216, the processor 106 determines a ramp profile whichspecifies the characteristics of the pressure wave to be transmitted tothe patient over the duration of the ramp period. In certainembodiments, the ramp profile is determined based on one or more of theramp duration identified at the step 210, the initial treatment energylevel identified at the step 212, and the ramp function identified atthe step 214. For the example given above, the ramp profile is definedas a linear ramp function with an initial treatment energy of 1.4,delivered over (⅓*3000)=1000 pulses, and increasing 0.0006 bar perpulse.

At the step 220, the processor 106 determines a therapy profile whichspecifies the characteristics of the pressure wave to be transmitted tothe patient over the course of the pressure wave treatment. If theprocessor determined that a ramp portion was to be included in thepressure wave treatment (at the step 208), the therapy profile willinclude the ramp profile determined at the step 216.

At the step 222, the processor 106 evaluates the therapy profiledetermined at the step 220 against a set of pressure wave treatmentcriteria. These criteria may be stored in the memory 110 coupled to theprocessor 106, and may represent limitations of the pressure wavetherapy device 110 (e.g., ranges of energy level and frequency that thepressure wave therapy device is capable of providing), patient safetylimitations (e.g., a maximum energy level that should not be exceededfor a particular treatment site), or any combination of such criteria.If the processor 106 determines that the therapy profile does not meetrequired criteria, the therapy profile is adjusted at the step 224. Incertain embodiments of the step 224, the processor 106 prompts theoperator to input different treatment parameters (e.g., by performingone or more of the steps 202-214). In other embodiments of the step 224,the processor 106 automatically adjusts the therapy profile so that itmeets the required criteria. To do this, the processor 106 may implementany one of a number of optimization techniques. For example, theprocessor 106 may determine the sensitivity of the required criteria toperturbations in the parameters of the therapy profile, and then adjustselected parameters to which the criteria are most sensitive.

If the processor 106 determines that the therapy profile meets therequired criteria at the step 222, the processor determines (at the step226) the control commands to be issued to the pneumatic and mechanicalcomponents of the pressure wave therapy device in order to achieve thetherapy profile. For example, the processor may generate and transmitvoltage control signals to a variable pneumatic pressure device and/or amechanical switch. Therapy devices including similar components,suitable for use with the systems and techniques disclosed herein, aredescribed in Wess, U.S. Pat. No. 5,795,311, issued Aug. 18, 1998; Wess,U.S. Pat. No. 6,059,741, issued May 9, 2000; Marlinghaus, U.S. PatentApplication Publication No. 2002/0002345, published Jan. 3, 2002; Schulzet al., U.S. Patent Application Publication No. 2006/0025710, publishedFeb. 2, 2006; Hagelauer, U.S. Patent Application Publication No.2009/0156894, published Jun. 18, 2009; Heine et al., U.S. PatentApplication Publication No. 2009/0326425, published Dec. 31, 2009; andMarlinghaus et al., and U.S. Patent Application Publication No.2009/0221940, published Aug. 13, 2009. In certain embodiments, todetermine the necessary control signals to provide to the pneumatic andmechanical devices, the processor 106 uses a look-up table or functionstored in the memory 108 to identify the appropriate control signals tosend to these devices to achieve the pressure wave treatment specifiedby the therapy profile.

At the step 228, the processor 106 provides the control signals to thepressure wave therapy device 110 to provide treatment according to thetherapy profile determined at the step 220 or 224. In certainembodiments, as described above, the treatment includes a ramp portion,during which the energy of the pressure wave transmitted to the patientincreases from an initial level to a target level. At the step 230, theprocessor 106 determines whether the treatment has been applied for theduration identified at the step 204 and is thus complete. If thetreatment is complete, the processor 106 executes the step 232(discussed in detail below). If the treatment is not yet complete (e.g.,during or after the ramp portion), the processor 106 may execute anumber of checks on the performance of the pressure wave therapy deviceand inputs from the operator and patient. For example, at the step 234,the processor determines whether the operator has changed the targetenergy level from the level identified at the step 206. If the energylevel has been changed, the processor performs an energy level changeprotocol at the step 236. In some embodiments, the energy level changeprotocol includes ignoring the change in target energy level andcontinuing to provide treatment according to the therapy profiledetermined at the step 220 or 224.

An exemplary energy level change protocol is illustrated in FIG. 2(b).At the step 250, the processor 106 determines whether the ramp portionhas been completed. If the ramp portion has been completed, in the step252, the processor 106 may adjust the energy level; the processor 106may additionally or alternatively terminate the applied treatment, atwhich point the processor 106 may return to an earlier step in theprocess (e.g., the step 206). If the ramp portion has not beencompleted, the processor 106 determines at the step 254 whether the newtarget energy level is less than or equal to the current energy levelbeing delivered to the patient. If the new target energy is less than orequal to the current energy level being delivered to the patient, at thestep 256, the processor 106 adjusts the therapy profile so the remainingtreatment is provided at the new target energy level. If the new targetenergy level is greater than the currently energy level, at the step258, the processor 106 will adjust the therapy profile according to theramp function. For a linear ramp function, one or more subsequent pulsesincrease in energy according to the following equation:

${{Energy}\mspace{14mu} {Change}\mspace{14mu} {per}\mspace{14mu} {Pulse}} = \frac{{{New}\mspace{14mu} {Target}\mspace{14mu} {Energy}} - {{Current}\mspace{14mu} {Energy}}}{\left( {\frac{1}{3}*{Pulses}\mspace{14mu} {in}\mspace{14mu} {Treatment}\mspace{14mu} {Duration}} \right) - {{Pulses}\mspace{14mu} {Already}\mspace{14mu} {Delivered}}}$

For example, if the new target treatment energy is 2.2 bar, the currentenergy is 1.7 bar, there are 3000 pulses in the treatment duration, and500 pulses have already been delivered, the new energy change per pulseis calculated as follows:

$\frac{{2.2\mspace{14mu} {bar}} - {1.7\mspace{14mu} {bar}}}{\left( {\frac{1}{3}*3000\mspace{14mu} {pulses}} \right) - {500\mspace{14mu} {pulses}}} = {0.001\mspace{14mu} {bar}\text{/}{{pulse}.}}$

Returning back to FIG. 2(a), at the step 138, the processor 106determines whether the operator has changed the treatment duration fromthe duration identified at the step 204. If the treatment duration hasbeen changed, the processor performs a treatment duration changeprotocol at the step 240. An exemplary treatment duration changeprotocol is illustrated in FIG. 2(c). At the step 260, the processor 106determines whether the ramp portion has been completed. If the rampportion has been completed, in the step 262, the processor 106 in someimplementations adjusts the remaining treatment duration, and in otherimplementations terminates the applied treatment, at which point theprocessor 106 may return to an earlier step in the process (e.g., thestep 206). If the ramp portion has not completed, the processor 106identifies at the step 264 a new ramp duration using the new treatmentduration (e.g., using any of the techniques described above for the step210). At the step 266, the processor 106 then determines whether the newramp duration is less than or equal to the applied duration (e.g., thenumber of pulses already applied or the elapsed time). If the new rampduration is less than or equal to the applied duration, at the step 268,the processor 106 ends the ramp portion and adjusts the remainingtreatment duration. In other implementations, rather than suddenlyincreasing the energy level, the processor 106 may finish the rampportion and only adjust the duration of the treatment portion after theramp, or the processor 106 may be configured to accelerate, but notcompletely eliminate, the remainder of the ramp portion. If the new rampduration is greater than the applied duration, at step 270, theprocessor 106 will adjust the therapy profile according to the rampfunction. For a linear ramp function, one or more subsequent pulsesincrease in energy according to the following equation:

$\left\lbrack {{{Energy}\mspace{14mu} {Change}\mspace{14mu} {per}\mspace{14mu} {Pulse}} = \frac{{{Target}\mspace{14mu} {Energy}} - {{Current}\mspace{14mu} {Energy}}}{\left( {\frac{1}{3}*{Pulses}\mspace{14mu} {in}\mspace{14mu} {New}\mspace{14mu} {Duration}} \right) - {{Pulses}\mspace{14mu} {Already}\mspace{14mu} {Delivered}}}} \right.$

For example, if the target treatment energy is 2.0 bar, the currentenergy is 1.7 bar, 500 pulses have been delivered, and the new treatmentduration is 1800 pulses, the new energy change per pulse is calculatedas follows:

$\frac{{2.0\mspace{14mu} {bar}} - {1.7\mspace{14mu} {bar}}}{\left( {\frac{1}{3}*1800\mspace{14mu} {pulses}} \right) - {500\mspace{14mu} {pulses}}} = {0.003\mspace{14mu} {bar}\text{/}{{pulse}.}}$

At the step 242, the processor 106 determines whether an indication hasbeen received that a patient tolerance threshold has been reached. Apatient tolerance threshold is reached when the patient or the operatorhas determined that the patient's discomfort is maximally tolerable (ortoo great) to continue the same treatment. The indication may bereceived by the processor 106 using any of a number of user inputsdescribed in relation to the pain threshold indicator 112 in FIG. 1. Theindicator may be received at any point during the treatment, includingduring a ramp portion of the treatment.

If the processor 106 determines at the step 242 that a patient tolerancethreshold indicator has been received, the processor 106 identifies thecharacteristics (e.g., energy level, frequency) of the treatmentdelivered to the patient at the time or approximate moment at which theindicator was received. These settings may be displayed for the operatorand patient and/or recorded in memory. At the step 246, the processor106 determines whether the treatment should be discontinued. Theprocessor 106 may make this determination by querying the memory 108 inwhich an operator or patient preference has been stored. In certainembodiments, an operator is given the option to specify that treatmentis to be discontinued when a patient tolerance indicator is received.When such an option has been selected by an operator and a patienttolerance indicator is received at the step 242, treatment will bediscontinued and the processor 106 will execute the step 232 (describedin detail below).

If the processor 106 determines that treatment is not to be discontinuedat the step 246, the processor proceeds to the step 248 and adjusts theremaining therapy profile to alleviate the patient's discomfort. Incertain embodiments, the processor performs the step 248 by adjustingthe energy level of the remaining treatment to a level below the energylevel at which the patient tolerance indicator was received (referred toas the “tolerance energy level”). The energy level may be reduced to alevel that is a fixed amount below the tolerance energy level (e.g., 0.1bar below the tolerance energy level). The energy level may be reducedto a level that is a fixed percentage below the tolerance energy level(e.g., 95% of the tolerance energy level). The energy level may bereduced to a predetermined level (e.g., 2 bar). Once the processor 106has adjusted the therapy profile for the remaining treatment, theprocessor 106 provides control signals to the pressure wave therapydevice 110 in accordance with this adjusted therapy profile (returningto the step 228).

Once the treatment duration has been reached (as determined at the step230), or the 106 processor determines that the treatment should beterminated at the step 246, the processor 106 indicates to the operator(e.g., via a display or printout), and/or records in memory 108,parameters describing the completed therapy session. Suitable parametersinclude any one or more of the therapy profile, the ramp profile,treatment characteristics at the time of patient tolerance indicators,physiological feedback or performance data indicating patient responseto the treatment, or any data useful to a care provider or patient fortracking the patient's progress during and across pressure wavetreatment sessions.

A simplified treatment editing screen 300 from the user interface 104 ofthe control unit 102 is shown in FIG. 3. In this embodiment, the userinterface 104 is a touchscreen display. The edit treatment screen 300includes treatment selection buttons 302-306, treatment selection numberlines 308-312, a save button 314, and navigation buttons 316 and 318.The mode button 402 opens a subscreen or navigates to a different screento allow the operator to select a treatment mode, e.g., pulses appliedcontinually or in bursts or sets. The ramp button 404 opens a subscreenor navigates to a different screen to allow the operator to identify howmuch of the total treatment duration should be used in the ramp portion.The handpiece button 406 opens a subscreen or navigates to a differentscreen to allow the operator to identify which pressure wave therapydevice is connected. The number lines for energy 408, frequency 310, andnumber of pulses 412 show the settings for the treatment factors. Theoperator can adjust these by sliding the marker along the number line orusing the up and down arrows to move in discrete steps. Once theoperator is satisfied with the treatment parameters, the operator maysave the treatment settings for future use with the save protocol button314. The save protocol button 314 may cause an on screen keyboard toappear, allowing the operator to enter a title for the protocol. Theback button 316 returns the interface to a previous screen, and the homebutton 318 returns the interface to a home screen. A screen containingsimilar information including the mode, ramp, handpiece, energy, pulses,and frequency of the treatment session could be displayed at the end ofthe treatment session. Such a treatment results screen may include theoption to save the protocol so that it may be used again.

As discussed above, in addition to manually entering the treatmentparameters, the user interface may allow the operator to retrievetreatment programs saved on memory for particular therapies or patients.When the operator selects a saved treatment program, he may be allowedto edit it through the edit treatment screen 300 before starting thetreatment.

A plot showing several treatment profiles is shown in FIG. 4. The plot400 shows the amount of energy delivered in each pulse in according tovarious types of ramp-up functions that may be used in pressure wavetherapy. The vertical axis of graph 400 shows the energy delivered ineach pulse, and the horizontal axis shows a duration, determined bynumber of pulses. Labeled on the horizontal axis is a number of pulsesT, which is the cutoff between the ramp-up portion and the therapeuticportion. In these example profiles, roughly one third of the totalduration is dedicated to the ramp-up portion of duration T. The totalduration of the ramp-up portion and therapeutic portion combined may bein the range of 10-10000 pulses.

In the graphs shown on plot 400, the energy per pulse during thetherapeutic portion 412, i.e., in the duration after T, is constant.This is often the case in pressure wave therapy, unless the treatment isinterrupted or the energy is decreased due to patient pain. However,many different ramp-up functions may be used. Three illustrative ramp-upgraphs 406-410 illustrating different ramp-up functions are shown. Graph406 shows a linear ramp-up, where each subsequent pulse is at a slightlyhigher energy than the previous pulse, and the incremental energy isconstant. Graph 408 shows a curved ramp-up, where each subsequent pulseis again at a slightly higher energy than the previous pulse, but theincremental energy decreases with each subsequent pulse. Graph 410 showsa stepped ramp-up, where the energy increases after a fixed number ofpulses, and the incremental energy is greater than in graph 406 or graph408.

In addition to ramping the energy per pulse, the processor 106 may beconfigured to ramp the frequency of the pulses. During the ramp-upportion, the processor 106 may additionally cause the frequency ofpulses to increase, which decreases the time between pulses. This mayfurther help a patient ease into the treatment.

It is to be understood that while systems, methods, and components havebeen described in conjunction with the various illustrative examples,the forgoing description is merely illustrative and does not limit thescope of the disclosure. While several examples have been provided inthe present disclosure, it should be understood that the disclosedsystems, components, and methods may be embodied in many other specificforms without departing from the scope of the present disclosure.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure. The disclosed features may beimplemented, in any combination and sub-combinations (including multipledependent combinations and sub-combinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems. Moreover, certain features may be omitted or notimplemented.

Examples of changes, substitutions, and alterations are ascertainable byone skilled in the art and could be made without departing from thescope of the information disclosed herein. All references cited hereinare incorporated by reference in their entirety and made part of thisapplication.

1. (canceled)
 2. (canceled)
 3. A pressure wave therapy systemcomprising: a pressure wave therapy device configured to deliveracoustic pulses to a patient, the pressure wave therapy devicecomprising: a ballistic projectile positioned within a tube, and atransmitter tip disposed at the end of the tube, wherein compressed airaccelerates the ballistic projectile through the tube to impact thetransmitter tip to generate an acoustic pulse; and a control unitconfigured to control the pressure wave therapy device to deliver atreatment program, the treatment program comprising a plurality ofacoustic pulses, each acoustic pulse comprising a pressure, the controlunit including a memory storing patient-specific treatment informationrelating to a pain threshold of the patient; and a pain thresholdindicator operable by the patient to provide an indication of a painthreshold of the patient.
 4. The pressure wave therapy system of claim3, wherein the patient-specific treatment information stored in thememory includes a pain threshold of the patent determined during aprevious treatment program.
 5. The pressure wave therapy system of claim3, wherein, when the patient operates the pain threshold indicator, thecontrol unit is configured to store a current pressure of an acousticpulse delivered by the pressure wave therapy device as the painthreshold of the patient in the memory.
 6. The system of claim 3,wherein the treatment program comprises: a desired target pressure forthe acoustic pulses delivered by the pressure wave therapy device; atherapeutic duration; and a ramp-up profile comprising an initialtreatment energy level and a ramp-up duration for controlling the outputpressure wave therapy device during a ramp-up period, wherein thepressure specified by the ramp-up energy output profile incrementallyincreases over the ramp-up duration as a function of the desired targetpressure and the ramp-up duration.
 7. The system of claim 6, wherein theramp-up profile is further configured as a polynomial function, anexponential function, a linear function, an affine function or astep-wise function.
 8. The system of claim 6, wherein the ramp-upprofile is configured to control delivery of acoustic pulses during theramp-up period, and to provide a pressure level that incrementallyincreases as a function of the number of pulses delivered.
 9. The systemof claim 6, wherein the control unit is configured to provide pneumaticcommands for controlling the pressure wave therapy device to deliver thetreatment program.
 10. The system of claim 6, wherein the control unitis configured to adjust the ramp-up energy profile when an indication ofa pain threshold of the patient is received from the pain thresholdindicator.
 11. The system of claim 10, wherein, when the indication ofpain threshold is received during the treatment program, the controlunit adjusts the treatment program.
 12. The system of claim 11, whereinthe adjustment to the treatment program comprises stopping the treatmentprogram.
 13. The system of claim 11, wherein, when the indication of thepain threshold is received during the ramp-up period, the adjustment tothe treatment program comprises setting the desired target pressure as acurrent pressure delivered by the pressure wave therapy device.
 14. Thesystem of claim 11, wherein, when the indication of the pain thresholdis received after the ramp-up period, the adjustment to the treatmentprogram comprises decreasing the therapeutic duration.
 15. The system ofclaim 11, wherein, when the indication of the pain threshold is receivedafter the ramp-up period, the adjustment to the treatment programcomprises decreasing the desired target pressure.
 16. The system ofclaim 3, wherein the pain threshold indicator comprises a microphone.17. The system of claim 3, wherein the pain threshold indictor comprisesa touchscreen input.
 18. The system of claim 3, comprises a handheldcomponent including a button or a dial.
 19. The system of claim 3,wherein the pressure wave therapy device is configured to delivertherapeutic energy at a frequency of approximately 0.5-35 Hz, at apressure of 1.0-5.0 bar, and in 10-10000 pulses delivered in a ramp upportion and a therapeutic portion.
 20. The system of claim 3, furthercomprising a user interface that receives a change to a therapyparameter.
 21. The system of claim 20, wherein the control unit isconfigured to: automatically adjust the treatment program to meetrequired criteria stored in the memory; receive, from the userinterface, an input from a user to change a therapy parameter;automatically adjust the treatment program when the input to change thetherapy parameter is received; and instruct the device to provide thetreatment program according to the adjusted therapy profile.
 22. Thesystem of claim 21, wherein the automatically adjusting the ramp-upenergy output profile further comprises adjusting a target energy levelof the ramp-up energy output profile.